BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFILE MD V-186 SERIES TIERED THERAPY DEFIB.

    MDR report key: 361982 · Received November 19, 2001

    Report

    Report Number
    2938836-2001-00408
    Event Type
    Injury
    Date Received
    November 19, 2001
    Date of Event
    August 15, 2001
    Report Date
    August 15, 2001
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ST. JUDE MEDICAL IN 10/2001 THAT THE DEVICE WAS EXPLANTED IN 2001 WHEN THE DEVICE WOULD NOT COMMUNICATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52345 PROFILE MD V-186 SERIES TIERED THERAPY DEFIB. IMPLANTABLE CARDIAC DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-186HV3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other THERAPY DATES: NA.